Informed consent irregularities remain one of the leading findings in FDA and EMA inspections. Join us as we examine real examples of FDA warning letters addressing informed consent inspection findings and discuss appropriate corrective and preventative actions (CAPAs), devising solutions to avoid common informed consent pitfalls and ultimately avoid inspection findings. Attendees are encouraged to share their experiences as we discuss methods and tools to aid in compliance with appropriate techniques for the informed consent process. Tools will be provided to assist with compliance.
Tuesday, January 23 at 11:00am to 12:00pm
1300 York Ave., New York NY 10065